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FDA Considering Revision Of Accuracy Standards For Home Glucose Monitors

The US Food and Drug Administration (FDA) said it would press for increasing the international accuracy standards for home glucose monitors used by diabetics in the US, according to New York Times. The rise in the use of home glucose monitors, also in hospitals, is pushing the Food and Drug Administration toward a possible crack-down on accuracy standards. Current standards allow the home glucose monitors to be wrong by as much as 20%.

Such a wide error rate (20%) can leave patients vulnerable to severe problems, including seizures, unconsciousness and coma.


In June 2009, the FDA started pressuring the International Organization for Standardization, which sets the standards,to tighten them. If that group refuses to act, the FDA may instead recognize other (higher) performance standards on its own, according to a June letter from agency commissioner Dr. Margaret Hamburg.


A recent study by government researchers comparing tests from five different popular meters revealed that results varied by as much as 32%. And a similar student project found that almost all of the meters were off from one another by 60 to 75 points.”